Artifical sphincter for controlling urinary incontinence

ABSTRACT

An artificial sphincter for the control of urinary incontinence is provided by wrapping around the urethral canal an inflatable plastic collar connected to a system of small pumps and valves governing the flow of fluid into and out of a fluid reservoir. The valves and pumps are so arranged that inflation and deflation of the collar is carried out in incremental steps, so that the applied pressure or release of pressure is graduated and controlled.

United States Patent 191 McWhorte'r et al.

[ 1 July 10, 1973 [s41 ARTIFICAL SPHINCTER FOR CONTROLLING URINARY INCONTINENCE [75] Inventors: Daniel M. McWhorter, Arlington Heights; Glenn N. Taylor, Cary, both of I11.

[73] Assignee: The Kendall (Iompany, Walpole,

Mass.

221 Filed: Oct. 12,1971

211 Appl.No.: 188,585

Related U.S. Application Data [63] Continuation of Ser. No. 888,368, Dec. 29, 1969,

abandoned. I

[52] U.S. Cl 3/1, 128/1 R, 128/346, l28/DIG. 25 [51] Int. Cl A61i l/00, A6lb 17/00 [58] Field of Search 3/1; 128/1 R, 327, 128/344, 346, DIG. 25

[56] References Cited UNITED STATES PATENTS 2,533,924 12/1950 Foley 128/346 6/1950 Jones 128/327 2,455,859 12/1948 Foley 128/346 FOREIGN PATENTS OR APPLICATIONS 8/1967 Netherlands 3/1 Primary Examiner-Richard A. Gaudet Assistant Examiner-Ronald L. Frinks Attorney-John F. Ryan [57] ABSTRACT An artificial sphincter for the control of urinary incontinence is provided by wrapping around the urethral canal an inflatable plastic collar connected to a system of small pumps and valves governing the flow of fluid into and out of a fluid reservoir. The valves and pumps are so arranged that inflation and deflation of the collar is carried out in incremental steps, so that the applied pressure or release of pressure is graduated and controlled.

9 claims, 8 Drawing Figures Pmmw 3.144.063

mwanr's FIG 2 I 1 30 I. 24

/I8 26 I, 20 L AJ 11 FIG 3 This is a continuation of application Ser. No. 888,368, filed Dec. 29, 1969 and now abandoned.

This invention relates to a device for controlling the flow of fluid. More particularly, it relates to a controllable sphincter device by means of which a controllable degree of restrictive pressure may be applied to a body passage as, for example, in the control of urinary incontinence.

Urinary incontinence, whether due to anatomical or neurological causes, is a serious problem, and numerous attempts have been made to solve it. Among these, the simplest method is not to regulate the flow at all, but to collect the urine in a bag or pouch affixed to the body. Such devices are generally cumbersome, odorous, and demand constant attention to sanitation.

An alternative prior art device is the use of clamps, of various contours and configurations, intended'to restrict the urethra by external compression ofthe entire penis, an uncomfortable expedient.

Still a third procedure for coping with the problem is an artificial sphincter appliedto the urethral passage, as described in US. Pat. No. 2,455,859. Such devices, meritorious as they may be, are lacking in the features of comfort, versatility, and variable control which are desirable in a device of this nature. It is with improvements in devices of this type that'the present invention is concerned.

It is an object of this inventionto provide an artificial sphincter capable of applying graduated degrees of restriction to a body passage.

It is a further object of this invention to provide a comfortable controllable sphincter which may be wholly implanted in the human body.

It is still another object of the invention to provide .an

controllable sphincter which may be controlled by digital pressure.

Other objects of the invention will appear more fully from the following description and drawings, in which FIG. 1 is a perspective view of the device of this invention.

FIG. 2 is a side elevation of the reservoir-valve-pump section 10 of FIG. 1.

FIG. 3 is a flow diagram illustrating the operation of the device of FIG. 1.

FIG. 4 is a front elevation of the urethral collar 12 of FIG. 1, in an inflated state.

FIG. 5 is a perspective view of the collar of FIG. 4.

FIG. 6 is a perspective view of an alternative type of inflation collar or cut-off device.

' FIGS. 7 and 8 are views of embodiments of one-way valves suitable for use in the valve chambers of this invention.

Referring to FIG. 1, the controllable sphincter of the present invention is seen in its preferred form as comprising a reservoir-valve-pump system 10 connected to an urethral collar 12 by means of a connecting tube 14. The reservoir-valve-pump system 10 may be composed principally of a soft, essentially flaccid polymeric material, such as natural or synthetic elastomers, silicone resins, and the like. It is conveniently formed in two pieces, as shown in 'FIG. 2, composed of an essentially flat slab or thin block of polymer 11, with the various cavities for the valves, pumps, and reservoir moulded or cast into an upper and coextensive block of polymer 13, blocks 11 and 13 being adhesively or thermally united around their peripheries and on both sides of the fluid channels, the reservoir, and the pumps, as shown by cross-hatching in FIG. 1.

In cases of incontinence which promise to be permanent or of long duration, it may be desirable thatthe device be permanently implanted in the body. In such instances, it is composed of materials which are nonirritating and non toxic. For cases of temporary incontinence, where the device may be worn in a pocket or attached to the clothing, the reservoir-valve-pump section may be fashioned from any convenient materials.

As shown in FIGS. 1 and 2, the hydraulic system comprises a fluid reservoir 18, two digitally operated hollow chamber pumps 24 and 30, and four one-way valves set in valve chambers 20, 22, 26, and 28, all these parts being interconnected in series. The two lower valves 20 and 26 operateto allow a fluid flow from the viewers left to right: the two upper valves allow'flow from viewers right to left, in the flow diagram shown in FIG. 3. The opposite direction of flow is of course equally effective and may be attained by reversing the flow direction of the one-way valves.

Preferably, the domes of the pump chambers 24 and 30 are resiliently depressable, while the outer wall of the reservoir 18 is limp and-collapsible, but does not exert an appreciable positive pressure on the fluid whichit contains.

The device as put into operation is normally filled with fluid such as sterile water, the total capacity of the system being, for example, 5 to 10 cubic centimeters,

the major portion of which resides in the reservoir 18.

In order to make the inflation pouch 38 as limp and flat as possible prior to its being wrapped around the urethral canal, any fluid in the pouch and in the connecting tube 14 may be transferred back to the reservoir 18 by depressing and releasing the depressable dome of the pump chamber 30. The four one-way valves all operate under somedegree of positive pressure: therefore, transfer of fluid from chamber 30 to reservoir 18 causes a relative vacuum in the chamber 30 when the resilient dome springs back. Fluid is thereby drawn from the pouch 38 down through the valve 28 to the chamber 30.

After the urethral collar has been secured in place as described below, digital pressure on the depressable dome of the pump chamber 24 forces fluid upwardly out of the pump and through the one-way valve chamber 22.

The hydraulic pressure necessary to operate the valve in chamber 28 is greater than the pressure necessary to inflate the inflatable section 38 of the urethral collar 12, as discussed below: therefore, the course of fluid flow is out of the reservoir-valve-pump system 10, through the connecting tube 14 and into the inflatable collar 12.

The hydraulic pressure necessary to operate the valve in chamber 28, however, should be so selected that when the inflatable section of the urethral collar has been inflated sufficiently to constrict the urethral canal to shut off urinary flow, further accidental pumping of fluid will not deliver more fluid to the collar, but will instead deliver fluid through the valve in chamber 28 and thence back to the reservoir. The valve in chamber 28 therefore acts as a safety shunt to prevent the application of a painful or dangerous degree of constriction through the inflatable collar. The dimensions of the pump 24 are preferably such that approximately one cubic centimeter offluid is ejected into the inflation collar 14 for each average stroke of digital pressure applied. Release of the pressure creates a negative pressure in the pump 24 with respect to the larger reservoir 18, equilibrium being reestablished by the automatic passage of fluid from the reservoir 18 through the one-way valve 20 and thence into the pumping chamber 24. Simple repetition of the pumping operation by the alternate application and release of pressure on the pump chamber 24 results in the gradual transfer of sufficient fluid to the urethral collar 12 to cut off the flow of urine by collapsing the urethral passage, as explained below.

The uretheral collar into which fluid is pumped by manipulation of the pump 24 is shown in perspective in FIG. 1. A generally rectangular strip of soft, pliable film 32 is heat-sealed or otherwise adhesively secured to a coextensive strip of a somewhat less pliable film 34, adhesion being peripheral as shown by the cross-hatched area 40. The connecting tube 14 is sealed into the assembly. By this peripheral sealing of the two strips of film, a pouch 38 is formed, inflatable by fluid delivered through the sealed-in tube 14.

In application, a longitudinal segment of the urethral canal, together with a certain amount of surrounding tissue, is separated from its surroundings. As shown in FIG. 5, the introduction of fluid into the urethral collar causes the inflation pouch 38 to enlarge, thereby compressing the tissue 50 and constricting the urethral canal 52 to the extent needed to shut off urinary flow. The overwrap 36 shown in FIGS. 1, 4 and is a flexible wraparound strip, generally long enough to be wrapped for a multiplicity of turns around the wrapped urethral collar. It is adhesively attached to the collar 12 as shown at 42 in FIG. 1, and is a soft, strong, comformable strip such as a close-weave polyester fabric reinforced by and impregnated with an elastomeric. silicone resin. Although this wraparound strip 36 is shown as pendent in FIG. 1, in actual use it is wrapped around the urethral collar 12, once the latter is in place, as shown in FIGS. 4 and 5. The strip 36 is then attached to the collar, adhesively or by stitching, and serves to maintain the collar in position.

The degree of pressure needed to restrict the passage of urine is a highly variable factor, influenced by anatomical, emotional, and neurological conditions. Although a figure of millimeters of mercury has been mentioned, it has been estimated that the necessary pressure may range from 5 to 50 millimeters of mercury. Prior art devices which apply fluid inflation to an urethral collar suffer from the fact that there is no graduated degree of control in the applied pressure, total pressure being applied or released in a single operation. The degree of variable control offered by the present invention affords a wide latitude of applied pressure, which may be varied at will by the wearer to suit his particular circumstances.

Deflation, with release of compression around the urethral canal, is effected by digital pressure on the pump chamber 30, which forces an amount of fluid through the one-way valve 26 and into the reservoir 18.

Release of pressure on the pump chamber 30 creates a partial vacuum within said chamber, resulting in the release of fluid from the urethral collar downwardly through the valve 28 and into the pump chamber 30. Digital pressure on the pump chamber 30 is repeated and released until the urethral canal has opened sufficiently to allow a satisfactory flow of urine, after which the inflation cycle, set forth above, is repeated.

Variations on this principle of equilibrating pressure by incremental pumping of fluid will readily suggest themselves to those skilled in the art. In place of a urethral collar in the form of an inflatable flat strip, the embodiment of a constricting device shown in FIG. 6 may be employed. Here the fluid-carrying connective tube 14 is sealed to a collapsible length of plastic tubing 60, sealed at the opposite end. The tubing should be thin-walled enough to be wrapped spirally more or less like a tape around the tissue 50. When inflated by fluid pumped through the tube 14, however, the tubing 60 expands and eventually compresses the urethral canal 52. The tube 60 may conveniently be held in position by means of the suture plates 62 and 64, or may be tied to pelvic bone structures.

The one-way valves controlling the fluid flow in re sponse to the actuation of the pump chambers may be chosen from any of the well-known valve devices responsive to fluid pressure in a single direction. They may be slit valves 21 of resilient, deformable plastic material, as shown in closed position in FIG. 7. The slit valve 21, as shown, is in the shape of one-half of a tubular capsule open at one end and closed at the other, but provided with a slit 23 cut completely through the closed end. As long as the fluid pressure on both sides of the valve is equal, the valve remains closed. However, if an increment of fluid is delivered to the canal l7, raising the pressure at the input side of the valve, or if an increment of fluid is withdrawn from the chamber 20, lowering the pressure at the output side of the valve, the valve will open and will remain open until an equilibrium pressure is reestablished on both sides. The valves should be capable of maintaining an inequilibrium that is, they should not operate at very small pressure differentials. For this reason, the valve 21 is provided with a reinforcing collar 19, which allows a significant pressure differential to be maintained on either side of the valve.

As an alternative, the valve may take the form shown in-FIG. 8, where a ball 25, loaded by a spring 27, closes the canal 17 so long as the fluid pressure in the chamber 20 is the same as in the canal. The spring 27 conveniently' rests on the downstream and against a sealed-in collar 29 provided with a central opening 31. In this modification, the pressure differential maintainabl'e on each side of-the valve' depends on the force exerted by the spring on the ball.

Various other expedients and arrangements in this and in the reservoir-valve-pump system may be used without departing from the spirit of the invention.

Having thus described our invention, we claim:

1. An artificial sphincter for controlling urinary incontinence which comprises i an inflatable urethral collar connected by a flexible tube to an inflation-deflation mechanism which comprises pump and valve means for incrementally increasing fluid pressure in said urethral collar,

and separate pump and valve means for incrementally decreasing fluid pressure in said collar.

2. The sphincter according to claim 1 in which the urethral collar is a substantially rectangular hollow inflatable plastic pouch.

3. The sphincter according to claim 1 in which the urethral collar is an extended length of collapsible plastic tubing sealed at one end and capable of being wrapped around the urethral canal.

4. The sphincter according to claim 1, said sphincter being made from a material which is non-toxic and non-irritating to the human body so as to be wholly implantable in fixed position within the human body.

5. The sphincter according to claim 1 wherein the inflatable urethral collar has attached thereto an elongated conformable generally rectangular strip of material which in length is greater than the circumference of the average urethral passage.

6. The sphincter according to claim 1 in which the pump and valve means for the inflation of the urethral collar and the separate pump and valve means for deflation of said collar are both connected to a single fluid reservoir.

7. An artificial sphincter in accordance with claim 1 wherein said inflation-deflation mechanism includes a fluid reservoir and wherein said pump and valve means for increasing fluid pressure in said collar, said reservoir, and said separate pump and valve means are interconnected in series in the order recited with the outlet side of said pump and valve means for increasing pressure in the collar connected to the inlet side of said separate pump and valve means,

said flexible tube interconnecting said collar with said inflation-deflation mechanism between said outlet side and said inlet side of the pump and valve means.

8. An artificial sphincter in accordance with claim 7 wherein each of said pump and valve means comprises, in series, a first one-way valve, a pump, and a second one-way valve,

said one-way valves permitting the flow of fluid from the reservoir to and from said collar through said tube when the pumps of the respective said pump and valve means are actuated.

9. An artificial sphincter in accordance with claim 8 wherein the first and second valves of the separate pump and valve means are pressure-actuatable, oneway valves which are actuatable to anopen position at a pressure greater the pressure of the inflated collar when the sphincter is in use to control urinary incontinency, whereby excess pressure created by pumping of the pump of said pump and valve means for increasing fluid pressure may be relieved by opening of said first and second valves at the excess pressure and the return of fluid therethrough to the reservoir. 

1. An artificial sphincter for controlling urinary incontinence which comprises an inflatable urethral collar connected by a flexible tube to an inflation-deflation mechanism which comprises pump and valve means for incrementally increasing fluid pressure in said urethral collar, and separate pump and valve means for incrementally decreasing fluid pressure in said collar.
 2. The sphincter according to claim 1 in which the urethral collar is a substantially rectangular hollow inflatable plastic pouch.
 3. The sphincter according to claim 1 in which the urethral collar is an extended length of collapsible plastic tubing sealed at one end and capable of being wrapped around the urethral canal.
 4. The sphincter according to claim 1, said sphincter being made from a material which is non-toxic and non-irritating to the human body so as to be wholly implantable in fixed position within the human body.
 5. The sphincter according to claim 1 wherein the inflatable urethral collar has attached thereto an elongated conformable generally rectangular strip of material which in length is greater than the circumference of the average urethral passage.
 6. The sphincter according to claim 1 in which the pump and valve means for the inflation of the urethral collar and the separate pump and valve means for deflation of said collar are both connected to a single fluid reservoir.
 7. An artificial sphincter in accordance with claim 1 wherein said inflation-deflation mechanism includes a fluid reservoir and wherein said pump and valve means for increasing fluid pressure in said collar, said reservoir, and said separate pump and valve means are interconnected in series in the order recited with the outlet side of said pump and valve means for increasing pressure in the collar connected to the inlet side of said separate Pump and valve means, said flexible tube interconnecting said collar with said inflation-deflation mechanism between said outlet side and said inlet side of the pump and valve means.
 8. An artificial sphincter in accordance with claim 7 wherein each of said pump and valve means comprises, in series, a first one-way valve, a pump, and a second one-way valve, said one-way valves permitting the flow of fluid from the reservoir to and from said collar through said tube when the pumps of the respective said pump and valve means are actuated.
 9. An artificial sphincter in accordance with claim 8 wherein the first and second valves of the separate pump and valve means are pressure-actuatable, one-way valves which are actuatable to an open position at a pressure greater the pressure of the inflated collar when the sphincter is in use to control urinary incontinency, whereby excess pressure created by pumping of the pump of said pump and valve means for increasing fluid pressure may be relieved by opening of said first and second valves at the excess pressure and the return of fluid therethrough to the reservoir. 